Core Insights - Company subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. received a Notice of Acceptance from the National Medical Products Administration for the new indication application of SHR-A1811 for treating locally advanced or metastatic HER2-positive breast cancer patients who have previously received one or more anti-HER2 therapies, and it has been included in the priority review process [1] Group 1 - SHR-A1811-Ⅲ-301 study is a randomized, open-label, positive drug-controlled, multi-center Phase III clinical trial designed to compare the efficacy and safety of SHR-A1811 with pyrotinib combined with capecitabine in HER2-positive breast cancer patients who have previously received one or more anti-HER2 therapies [2] - The primary endpoint is progression-free survival (PFS) assessed by a blinded independent radiology committee (BIRC) based on RECIST v1.1, with secondary endpoints including investigator-assessed PFS, overall survival (OS), objective response rate (ORR), and duration of response (DoR) [2] - In July 2025, the Independent Data Monitoring Committee (IDMC) reviewed the data and confirmed that the primary endpoint of BIRC-assessed PFS met the pre-specified superiority criteria, indicating that SHR-A1811 significantly reduces the risk of disease progression/death compared to the control group, with good safety [2] Group 2 - SHR-A1811 was approved for marketing in China in May 2025 for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy [3]

据悉，SHR-A1811-Ⅲ-301 研究为一项随机、开放、阳性药物对照、多中心设计的Ⅲ 期临床试验，旨在 比较 SHR-A1811 与吡咯替尼联合卡培他滨在既往接受过一种或一种以上抗 HER2 药物治疗的 HER2 阳 性乳腺癌患者中的有效性和安全性。本研究由中山大学孙逸仙纪念医院宋尔卫院士、姚和瑞教授共同担 任主要研究者，全国54 家中心共同参与。主要终点为盲态独立影像评审委员会(BIRC)基于 RECIST v1.1 评估的无进展生存期(PFS)。次要终点包括研究者基于 RECIST v1.1 评估的 PFS、总生存期(OS)、客观 缓解率(ORR)、缓解持续时间(DoR)等。2025 年 7 月，独立数据监查委员会(IDMC)审查数据并确认，在 方案预设的期中分析中，主要研究终点 BIRC 评估的 PFS 达到预设的优效标准。结果表明，与对照组 相比，瑞康曲妥珠单抗可显著降低患者疾病进展/死亡风险，且安全性良好。 公司注射用瑞康曲妥珠单抗已于 2025年5月在国内获批上市，适用于治疗存在 HER2(ERBB2)激活突变 且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌(NSCLC) ...

Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-146 江苏恒瑞医药股份有限公司 关于药物纳入拟突破性治疗品种公示名单的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年9月17日 於本公告日期，董事 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the new indication of SHR-A1811, a drug for treating HER2-positive breast cancer in patients previously treated with one or more anti-HER2 therapies, which has been included in the priority review process [1] Group 1 - The drug SHR-A1811 is intended for adult patients with locally advanced or metastatic HER2-positive breast cancer [1] - The acceptance of the new indication application indicates potential growth opportunities for the company in the oncology market [1] - The inclusion in the priority review process may expedite the approval timeline, enhancing the company's competitive position [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年9月17日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-14 ...

Core Insights - The article highlights the top and bottom AH share premium rates as of September 17, with Northeast Electric (00042) leading at a premium of 831.03% and Ningde Times (03750) at the bottom with -10.11% [1][2][3] Group 1: Top AH Share Premium Rates - Northeast Electric (00042) has the highest premium rate of 831.03% with a deviation value of 44.04% [2][4] - Andeli Juice (02218) follows with a premium rate of 236.50% and a deviation value of 8.97% [2] - Hongye Futures (03678) ranks third with a premium rate of 223.11% and a deviation value of -13.14% [2] Group 2: Bottom AH Share Premium Rates - Ningde Times (03750) has the lowest premium rate at -10.11% with a deviation value of 6.07% [3] - Heng Rui Medicine (01276) has a premium rate of -1.06% and a deviation value of 0.46% [3] - Midea Group (00300) shows a premium rate of 3.86% with a deviation value of -2.87% [3] Group 3: Top Deviation Values - Northeast Electric (00042) leads in deviation value at 44.04% with a premium rate of 831.03% [4] - Zhaoyan New Drug (06127) has a deviation value of 22.30% with a premium rate of 97.55% [4] - Zhejiang Shibao (01057) follows with a deviation value of 21.80% and a premium rate of 216.26% [4] Group 4: Bottom Deviation Values - Fudan Zhangjiang (01349) has the lowest deviation value at -22.95% with a premium rate of 195.69% [5] - Longyuan Power (00916) shows a deviation value of -21.66% with a premium rate of 163.60% [5] - Liaogang Co. (02880) has a deviation value of -20.47% with a premium rate of 105.66% [5]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of three injectable drugs, indicating progress in its oncology pipeline [1] Group 1: Drug Approvals - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd. have received clinical trial approval for SHR-1826, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - SHR-1826 is an antibody-drug conjugate targeting c-MET, designed to selectively bind to tumor cell surface antigens and induce cell death [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, aims to block the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] - Adebali monoclonal antibody injection (brand name: Ailili) was approved for market in March 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [1] - Bevacizumab is a humanized anti-VEGF monoclonal antibody, co-developed by Genentech and a Chinese pharmaceutical company, and has been marketed globally since its approval in the U.S. in 2004 [1] - The company's Bevacizumab injection was approved for market in June 2021, with multiple formulations currently available in China [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致之任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 2025年第一次臨時股東會的投票表決結果 董事會欣然宣佈，股東會已於2025年9月16日（星期二）下午二時三十分假座中國 上海市浦東新區海科路1288號舉行。 本公司所有董事、監事及董事會秘書均以親身或電子方式出席股東會。 出席股東會的股東及授權代表詳情載列如下： 江蘇恒瑞醫藥股份有限公司（「本公司」）宣佈於其2025年9月16日（星期二）舉行的 2025年第一次臨時股東會（「股東會」）上，所有提呈的決議案均以投票表決方式獲 正式通過。股東會由本公司董事（「董事」）會（「董事會」）召開。 有關決議案的進一步詳情載於本公司日期為2025年8月26日的股東會通告（「該通 告」）及同日的通函（「通函」）。 除非文義另有所指，否則本公告所 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年9月16日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-14 ...

Core Viewpoint - Heng Rui Medicine (01276) has announced a 2025 A-share employee stock ownership plan aimed at establishing a profit-sharing mechanism among the company, shareholders, and employees to enhance employee motivation, creativity, cohesion, and overall company competitiveness, promoting long-term and sustainable development [1] Summary by Relevant Sections - Employee Stock Ownership Plan Details - The plan involves the acquisition of up to 14 million A-shares (including reserved shares), accounting for approximately 0.21% of the company's total share capital as of the announcement date [1] - The acquisition price is set at 30.95 yuan per share, with the final number of shares held under the plan to be determined based on actual execution [1] - Participation and Eligibility - The total number of employees participating in the plan is expected to be no more than 1,316 (excluding reserved shares) [1] - Among the participants, the number of company directors (excluding independent directors), supervisors, and senior management is limited to no more than 9 (excluding reserved shares), with the final number of participants and subscription details to be confirmed based on actual employee contributions [1]